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STANDARD 2: Leadership

2.1 Dental Organization Managing Director 

1. The dental organization shall have a managing director responsible for the conduct of the dental organization. The managing director shall abide by national law and this standard in the operation of the dental organization. The managing director shall be aware of any internal and/or external influences or information likely to effect to the defined strategic directions and scope of services of the dental organization. Attention to and consideration of relevant customer needs and interested party’s satisfaction shall be required.

2. The managing director shall consider the following concepts in establishing the processes needed for the operation of the dental organization: a) a defined scope of practice based on risk analysis in order to achieve best practice results; b) an approach to practice which considers process interaction and sequences with the appropriate controls in order to achieve desired results; c) consideration of resources required for stable operation; d) the assignment of leadership authority as determined necessary; e) periodic review of practice processes in order to maintain patient satisfaction, quality outcomes, and continual improvement.

NOTE 1 Risk analysis requires consideration of preventive and/or corrective action within the dental organization (proactive and/or retroactive).

3. The managing director shall be accountable for all processes within the facility to establish and define:

 a) a quality policy; 

b) quality objectives in keeping with the strategic direction and scope of practice of the dental organization;

c) processes that integrate quality patient care and effective control of outsourced services 

d) processes that achieve intended results; 

e) how support personnel shall contribute to the effectiveness of the dental organization; 

f) an environment of patient focus and customer satisfaction throughout the dental organization; 

g) the maintenance documented information to support the operation of its processes as defined by national law, this standard, or as determined necessary within the dental organization; 

h) how changes within the dental organization shall maintain the stability and strategic direction of the dental organization; 

i) appropriate and timely response to any requirements and corrective actions requests from regulatory and accreditation agencies in compliance with national law and regulation; 

j) that the principles of ethics described in standard 3 are implemented and maintained; 

k) how input from service users, their families, local communities, and/or knowledgeable staff may improve the service provision of the dental organization; 

l) any published information relative to the quality performance of services provided by the dental organization.

This data shall be valid, verifiable, and current.

The following resources shall be available to the dental organization to achieve conformity, confidence, and stability of the processes within the scope of operations. These resources shall include but are not limited to the following: 

a) appropriate infrastructure; 

b) an environment ensuring a suitable psycho-social workplace;

 c) a culture of patient safety; 

d) equipment resources required to ensure valid and reliable provision of dental organization processes in a safe manner consistent with standard of care; 

e) confidence in critical measurements confirmed by periodic calibration of equipment utilized as required by the manufacturer or the determined need by the dental organization; 

f) organizational knowledge required for the successful operation of its processes;

g) competence of personnel with respect to their assigned duties and responsibilities;

h) awareness of personnel with respect to the quality policy and scope of dental organization processes to include emphasis on customer satisfaction and improved performance; 

i) communication within the dental organization to assure appropriate and timely availability of relevant documented information.

5. The managing director shall ensure that authority and areas of responsibility are established and understood within the dental organization.

NOTE 2 The managing director is required to show leadership and commitment. 

This means they are not only accountable for the effective implementation of the dental organization management system, but are also responsible for making people aware of:

a) quality goals and strategic direction and their contribution to help the dental organization reach those goals; 

b) responsibilities;

c) expectations (professional behavior and including personal leadership); 

d) customer focus.

NOTE 3 A managing director may decide to appoint appropriate leadership to monitor, measure, review and report internal quality issues to others to satisfy the requirements noted above.

2.2 Organizational Plan and Budget 

1. The dental organization shall have an overall financial plan that meets the following conditions: 

a) the plan shall include an annual operating budget that is prepared by qualified person(s) according to generally accepted accounting principles; 

b) the budget shall include all anticipated income and expenses.

2. This budget shall be reviewed in a timely manner to assure that the intent of the budget is met and consistent with both long term and short-term strategic plans. The managing director shall be responsible for outsourced services furnished within the dental organization. Contracted service shall comply with all requirements of applicable laws and this standard.

2.3 Outsourced Services

1.The managing director shall be responsible for outsourced services furnished within the dental organization. Contracted service shall comply with all requirements of applicable laws and this standard.

2. The managing director shall ensure that the services performed, or products supplied under a contract, are provided in a safe and appropriate manner.

3. The dental organization shall conduct a review of all outsourced services/products for satisfactory performance and outcomes when necessary or at least yearly.

4. The review of this monitoring and measurement shall be considered for contract renewal and ongoing selection of the outsourced services/products in question.

5. Documented information shall be retained as considered appropriate.